Back to resultsImmunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Primary Purpose
Allergy, Rhinoconjunctivitis
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Immunotherapy with modified extract of O. europaea pollen
Sponsored by
About this trial
This is an interventional treatment trial for Allergy focused on measuring Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
- Patients of both gender > 18 years old
- Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
- Specific IgE to Olea europaea
- Written informed consent
Exclusion Criteria:
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- Patients suffering from immune deficiencies
- Patients with serious psychiatric / psychological disturbances
- In addition, the following was considered as exclusion criteria:
- Pregnant or/ in lactation patients
- Patients aspirin intolerance
Sites / Locations
- Hospital Universitatio Ciudad de Jaén
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Biological Vaccine
Outcomes
Primary Outcome Measures
Symptom score
Secondary Outcome Measures
Dose-response skin prick-test
Medication score
Rhinoconjunctivitis quality of life questionnaire
Analogical visual scale
Serology
Record of adverse events
Full Information
NCT ID
NCT00537342
First Posted
September 28, 2007
Last Updated
December 16, 2010
Sponsor
Laboratorios Leti, S.L.
1. Study Identification
Unique Protocol Identification Number
NCT00537342
Brief Title
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Official Title
Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis
Detailed Description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Rhinoconjunctivitis
Keywords
Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Biological Vaccine
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Immunotherapy with modified extract of O. europaea pollen
Intervention Description
Sublingual (2 drops daily during 2 months)
Primary Outcome Measure Information:
Title
Symptom score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Dose-response skin prick-test
Time Frame
1 year
Title
Medication score
Time Frame
1 year
Title
Rhinoconjunctivitis quality of life questionnaire
Time Frame
1 year
Title
Analogical visual scale
Time Frame
1 year
Title
Serology
Time Frame
1 year
Title
Record of adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
Patients of both gender > 18 years old
Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
Specific IgE to Olea europaea
Written informed consent
Exclusion Criteria:
Use of immunotherapy during the last four years.
Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
Treatment with ß-blockers
Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
Patients suffering from immune deficiencies
Patients with serious psychiatric / psychological disturbances
In addition, the following was considered as exclusion criteria:
Pregnant or/ in lactation patients
Patients aspirin intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Luis Anguita, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitatio Ciudad de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
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